Agency classClass IIOur severity:Severe FDA (Devices)·Z-0650-2013·Announced 2013-01-16

California Medical Laboratories Recalls Rigid Tip Suction Wands Due to Tip Detachment Risk

California Medical Laboratories is recalling Rigid Tip Suction Wands because the distal tip may detach and fall into a patient's chest cavity during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device defect where a component may detach and enter a patient's chest cavity, posing a significant risk of serious injury, which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.

Plain-English summary

California Medical Laboratories, Inc. is recalling Rigid Tip Suction Wands (Catalog No: SU-12202NS) due to a manufacturing defect. The recall involves non-sterile bulk devices with lot numbers S112468N, S120196N, and S120197N. These devices were sold to Terumo UK to be included in kits under the Terumo brand name. The suction wands are indicated for use to remove excess fluid from the surgical field.

The recall was initiated because insufficient adhesive application on the devices creates a risk that the distal tip may come loose from the wand. If this occurs, the tip has the potential to fall into the patient's chest cavity during a surgical procedure.

The affected units were distributed worldwide, including in the United States (Arizona, Florida, California, Louisiana, Colorado, and Mississippi) and internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, the Netherlands, Russia, Saudi Arabia, South Africa, and Spain. The total quantity involved is 3,600 units (1,000 units of S112468N, 1,400 units of S120196N, and 1,200 units of S120197N). Healthcare facilities and distributors should stop using these devices and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Manufacturer: California Medical Laboratories Inc
Category: Medical Device — Surgical Instrument
Hazard: foreign-object
surgical-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Catalog No: SU-12202NS Lot No: S112468N
S120196N
S120197N

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by California Medical Laboratories Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · California Medical Laboratories Inc

See all →

Severe
California Medical Laboratories Recalls Sterile Rigid Tip Suction Wands
FDA (Devices) · 2013-01-16

Same hazard · foreign object